FDA Approves First Biosimilar Product

A biosimilar product is a biological product that is approved based on a relative relation to an already approved biological product.

Mar 08, 2015

The U.S. Food and Drug Administration has approved Zarxio, the first biosimilar product approved in the United States. A biosimilar product is a biological product that is approved based on a relative relation to an already-approved biological product.

Zarxio is biosimilar to Neupogen and is approved for the same indications. It can be prescribed by a health care professional for: patients with cancer receiving myelosuppressive chemotherapy, patients with acute myeloid leukemia receiving induction or consolidation chemotherapy, patients with cancer undergoing bone marrow transplantation, and patients with severe chronic neutropenia.

"Biosimilars will provide access to important therapies for patients who need them," said FDA Commissioner Dr. Margaret A. Hamburg, M.D. "Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency's rigorous safety, efficacy, and quality standards."

A biosimilar product can be approved by the only if it has the same mechanism(s) of action, route(s) of administration, dosage form(s) and strength(s) as the reference product, and only for the indication(s) and condition(s) of use that have been approved for the reference product, according to FDA's news release.

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